510(k) · Cleared
ClearedProvitemp, Dentotemp, Totalcem, Dentocem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Itena Clinical · EMA Cement, Dental
Cleared on Apr 19, 2013 as substantially equivalent to K032470 (Ivoclar Vivadent, Inc., 2003) and 2 other predicates after a 304-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Apr 19, 2013
- Review
- 304 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K924151 (1992). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK924151 Bisco D/C ResinomerBisco, Inc. · 1992
- 1 generation backK012316 Permacem / Permacem DualDmg USA, Inc. · 2001
- This deviceK121804 Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013
- Descendant · cites it directly · 0 of its ownK162960 TotalC-RamItena Clinical · 2017
Most influential descendants
Showing 1 of 1 · See all- K162960TotalC-RamItena Clinical · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924151 | Bisco D/C Resinomer | Bisco, Inc. | 1992 | — |
| −1 | K012316 | Permacem / Permacem Dual | Dmg USA, Inc. | 2001 | — |
| 0 (this device) | K121804 | Provitemp, Dentotemp, Totalcem, Dentocem | Itena Clinical | 2013 | — |
| +1 | K162960 | TotalC-Ram | Itena Clinical | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EMA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032470 | MultilinkSummary page 1…e: Dental Cement 7. Classification Product Code: EMA 8. Predicate Devices: TotalCen MultiLink _______________ K032470 _______________ DentoCem R LyXtting Plus Cement PremaCe… | 2003 |
| * | K022476 | Relyx Rmgip | 2002 |
| * | K012316 | Permacem / Permacem DualSummary page 1…oCem R LyXtting Plus Cement PremaCem K01 2316 _______________ K022 476 _______________ 9. Devices Description: TotalCem:… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162960 | TotalC-Ram | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K162960 (Itena Clinical, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032470.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
It is intended for the cementation of posts, crowns, bridges, inlays and onlays.
It is intended for permanent cementation of:
* crowns and bridges, inlays, onlays, posts and cores, ceramic crowns, Maryland bridges and veneers;
* implant prosthesis;
* orthodontic attachments;
* amalgam restorations;
* veneering of alloys; and
* composite restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121804: Provitemp, Dentotemp, Totalcem, Dentocem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121804
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026